WO2019075634A1 - Dilatable balloon catheter - Google Patents

Dilatable balloon catheter Download PDF

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Publication number
WO2019075634A1
WO2019075634A1 PCT/CN2017/106514 CN2017106514W WO2019075634A1 WO 2019075634 A1 WO2019075634 A1 WO 2019075634A1 CN 2017106514 W CN2017106514 W CN 2017106514W WO 2019075634 A1 WO2019075634 A1 WO 2019075634A1
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WO
WIPO (PCT)
Prior art keywords
catheter
balloon
guide wire
cavity
tube body
Prior art date
Application number
PCT/CN2017/106514
Other languages
French (fr)
Chinese (zh)
Inventor
盛畅
黄云腾
郑忠伟
钱维
严航
Original Assignee
上海英诺伟医疗器械有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海英诺伟医疗器械有限公司 filed Critical 上海英诺伟医疗器械有限公司
Priority to US16/651,958 priority Critical patent/US11504510B2/en
Priority to EP17928900.4A priority patent/EP3673948B1/en
Priority to JP2020509484A priority patent/JP6937091B2/en
Priority to PCT/CN2017/106514 priority patent/WO2019075634A1/en
Priority to ES17928900T priority patent/ES2929743T3/en
Publication of WO2019075634A1 publication Critical patent/WO2019075634A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/005—Flexible endoscopes
    • A61B1/01—Guiding arrangements therefore
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A61B2017/22045—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire fixed to the catheter; guiding tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22067—Blocking; Occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22082—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
    • A61B2017/22084—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance stone- or thrombus-dissolving
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0008—Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0186—Catheters with fixed wires, i.e. so called "non-over-the-wire catheters"
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1063—Balloon catheters with special features or adapted for special applications having only one lumen used for guide wire and inflation, e.g. to minimise the diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1068—Balloon catheters with special features or adapted for special applications having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M2039/229—Stopcocks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0266—Shape memory materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1025—Respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1042—Alimentary tract
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1078—Urinary tract

Definitions

  • the present invention relates to the field of medical devices, and more particularly to an expanded balloon catheter.
  • a prior art expanded balloon catheter such as the application number CN201520474689.1, relates to an occluder for use in lithotripsy, the occluder comprising a one-way valve switch, a catheter, a handle, a sealing ball a capsule, a protective film, a metal guide wire, a small hole;
  • the occlusion balloon is wrapped on the outer surface of the catheter, and forms a closed capsule with the catheter, the diameter of the capsule is 5-25 mm;
  • the occlusion balloon is elliptical a shape or a spherical shape having a length of 0.5 to 5 cm; a small hole is formed in the catheter wrapped around the balloon; a distal end of the catheter is fixedly connected with a metal guide wire; and the metal guide wire is protected by a protective film.
  • a proximal end of the catheter is fixedly connected to the handle; the handle is provided with a stripe; the one-way valve switch is connected at a proximal end of the catheter; the one-way valve switch is provided with a valve piece; The valve switch is connected to a syringe or inflation valve.
  • the catheter that is enclosed by the balloon is provided with a small hole, and the occlusion balloon and the lumen of the catheter communicate with each other through the small hole, and the liquid can be injected into the lumen of the catheter. Then enter the occlusion balloon to expand the balloon.
  • the catheter when the occlusion balloon of the utility model is longitudinally elongated in the water injection expansion, the catheter also becomes longitudinally stretched and deformed, and the deformation of the catheter is different due to the different materials.
  • the water-injected balloon is bent and deformed, which causes uneven expansion of the surface when the balloon is swollen, increases the difficulty of surgery, reduces the surgical treatment effect, and easily causes damage to the instrument.
  • the invention of application No. CN201510809012.3 provides a ureteral stone movement blocking device which is composed of a catheter (1), an expandable compression airbag (2) and a valve (3), and the catheter (1) has a flexible hollow length.
  • the tubular structure is made of elastic silicone or latex material, and the front end of the catheter (1) is provided with an opening in the airbag of the expandable compression airbag (2); the expandable compression airbag (2) is arranged in the catheter (1)
  • the front end of the tube has an expanded state of an ellipsoid shape; the valve (3) is located at the end of the catheter (1) and is provided with a syringe inlet (4).
  • the anterior segment of the catheter (1) of the device can enter the ureter through the operating cavity to fix the balloon (2) relative to the upper ureteral lumen of the stone or the outlet of the renal pelvis, thereby realizing the function of blocking the filling and watering of the water to the kidney, and completely Blocks any pathway in which stones may shift or escape to the renal pelvis.
  • the front end of the catheter (1) of the invention is provided with an opening in the airbag of the expandable compression airbag (2); the expandable compression airbag (2) is disposed at the front end of the catheter (1), such a folding guide guide Silk can't be set It is placed at the front end of the compression airbag, so that it can not be safely guided and marked by guiding the guide wire, thereby easily causing damage to the ureter and reducing the success rate of the operation.
  • the utility model of the application No. CN201120001866.6 discloses a ureteral catheter with a balloon, comprising: a tube body and an air bag, wherein: the air bag is located outside the tube body; both ends of the tube body are transparent, and the wall is in the air bag A through hole is arranged in the area; a baffle is arranged in the tube body, and the baffle divides the space inside the tube into two mutually independent cavities, respectively a water injection chamber and a guide wire cavity, wherein the water injection cavity is connected with the through hole. One end is provided with an opening, the other end is closed, and both ends of the guide wire cavity are transparent.
  • the utility model divides the space inside the tube body into two mutually independent cavities through the baffle, which are respectively a water injection chamber and a guide wire cavity, and the two different cavities are respectively arranged because the baffle plate is parallel to the axial direction of the ureteral catheter.
  • the required diameter of the tube increases the diameter of the catheter, which makes the diameter of the catheter thicker, which is not conducive to the catheter from the device channel into the human body, and further increases the suffering of the patient.
  • the above-mentioned prior art dilatation balloon catheter is limited by the diameter of the instrument tube which cannot be inserted into the endoscope, and is also prone to cause discomfort to the patient during the treatment process, which improves the difficulty of the operation operation, and when the airbag is longitudinally elongated in the water injection expansion. It is easy to bend and deform, thus reducing the effect of surgical treatment and easily causing damage to the instrument.
  • the invention discloses an expanded balloon catheter, comprising a catheter and a guide wire extending through the inside of the catheter.
  • the catheter is fixedly connected with an operation portion at one end, and the balloon is covered on the outer side of the distal end of the catheter remote from the operation portion.
  • the balloon lumen is communicated by a communication structure disposed on the catheter, the guide wire comprising a first guide wire and a second guide wire separated from each other in the balloon lumen, the rear end of the first guide wire being connected to the operation portion
  • the insertion and removal structure is fixed to the other end of the catheter by a fixing process.
  • the tube body is separated from the tube body region in the balloon into a first tube body and a second tube body, the rear end of the first tube body is fixedly connected to the operation portion, and the outer wall of the second tube body is fixedly connected to the balloon.
  • the cross section between the first tube body and the second tube body constitutes a communication channel, and the communication channel serves as a communication structure to connect the catheter cavity and the balloon lumen, and the insertion depth of the second guide wire into the first tube body is greater than The separation distance between the first tube body and the second tube body when the balloon 4 is inflated.
  • one or more through holes are provided in the tube wall of the catheter in the balloon, the through hole serves as a communication structure to communicate the catheter cavity and the balloon lumen, and the through hole 14 is disposed in the second guide wire to be inserted into the first tube The end of the body and the junction of the first tube and the balloon.
  • a developing ring is provided at a position where the front end of the balloon is connected to the second pipe body, and the inside of the duct in the region in the developing ring is closed.
  • the catheter is provided with a tip catheter away from the side of the operating portion, the second guide wire extending into the tip catheter, the end of the second guide wire in the tip catheter being at a distance of 0.5 mm to 2 mm from the tip end of the tip catheter.
  • the catheter is provided with a tip catheter away from the side of the operating portion, the second guide wire extends away from the operating portion to the outside of the tip catheter, and the portion of the second guide wire that is external to the tip catheter is configured as a spherical body structure.
  • the operating portion includes a hand-held portion, and the catheter is disposed inside the hand-held portion to form a liquid passage that communicates with the inner cavity of the balloon.
  • a rear end of the hand-held portion is provided with a two-way cock, and a plug of the two-way cock is provided with a cocking through hole.
  • a scale line is provided on the outer peripheral surface of the catheter at the rear end of the balloon.
  • the rear end of the operating portion is provided with an external thread
  • the external thread can be sleeved with the screw cap
  • the screw cap is connected as the insertion and extraction structure to the rear end of the first guide wire, and the first guide wire can be pulled out by removing the screw cap .
  • the dilatation balloon catheter of the present invention comprises a first guide wire and a second guide wire separated from each other, and the first guide wire can be inserted and removed through the opening at the rear end of the catheter, thereby making the guide wire cavity and the injection cavity
  • the same catheter cavity can be shared, no need to additionally set the injection cavity, or the protective wire is additionally provided on the surface of the guide wire to protect the guide wire, thus greatly reducing the diameter of the expanded balloon catheter of the embodiment, thereby
  • the dilatation balloon catheter of the present invention can be inserted into the narrow tube body or cavity of the human body through the instrument channel of the endoscope to realize visual operation, and has good practical value.
  • urinary system urinary
  • digestive system biliary duct, pancreatic duct
  • respiratory system airway
  • FIG. 1 is a partial structural view showing an expanded balloon catheter in an embodiment of the present invention
  • FIG. 2 is a schematic view showing another partial structure of an expanded balloon catheter according to an embodiment of the present invention.
  • FIG. 3 is a schematic view showing the overall structure of an expanded balloon catheter in an embodiment of the present invention.
  • a first embodiment of the present invention discloses an expansion balloon catheter including a guide wire 2 that is disposed inside the catheter 1 and the catheter 1 .
  • the catheter 1 is fixedly connected to the operation portion 3 at one end thereof, away from the operation portion.
  • 3 has a balloon 4 in the distal outer side of the catheter 1, and the lumen of the catheter 1 and the lumen of the balloon 4 are connected by a communication structure disposed on the catheter 1, wherein the guide wire 2 includes a separation from each other.
  • a guide wire 21 and a second guide wire 22, the rear end of the first guide wire 21 is detachably connected to the operation portion 3 by a plug-in structure, and the second guide wire 22 is fixed to the other end of the catheter 1 by a fixing process.
  • the guide wire 2 includes a first guide wire 21 and a second guide wire 22 which are separated from each other.
  • the first guide wire 21 can be inserted and removed through the insertion and extraction structure provided on the operation portion 3, and the first guide wire is inserted into the human body when the balloon catheter is inserted into the human body.
  • the wire 21 can be inserted into the catheter cavity through the insertion and extraction structure on the operation portion 3, the catheter cavity is used as a guide wire cavity to guide the guide wire, and the guide wire is used for guiding insertion. When the liquid is injected, the first guide wire 21 can be pulled out.
  • the catheter cavity is injected as a liquid injection cavity, so that the guide wire cavity and the injection cavity can share the same catheter cavity, no additional injection cavity is required, or a protective film is not required on the surface of the guide wire.
  • the guide wire is protected, so that the diameter of the expanded balloon catheter of the embodiment is greatly reduced, so that the expanded balloon catheter of the embodiment can be inserted into the human body through the instrument channel of the endoscope. Visualization is performed in the body or cavity body.
  • the liquid injected into the balloon is preferably physiological saline.
  • the physiological saline enters from the rear end of the catheter 1 because the front end of the catheter 1 is a closed structure, and the physiological saline flows out from the communicating structure provided on the catheter and Accumulated in the balloon 4, the balloon 4 is expanded and expanded outward, and when the physiological saline is withdrawn from the inside of the catheter, the balloon 4 is contracted back to the original state.
  • the inside of the catheter 1 is a hollow structure, and the front end of the catheter 1 is a closed structure, the rear end of the catheter 1 is an open structure, and the guide wire 2 is disposed inside the catheter 1 , and the lumen of the catheter 1 and the lumen of the balloon 4 are disposed at Connecting structure on the conduit 1 Connected.
  • the catheter 1 is separated from each other into the first tube body 11 and the second tube body 12 in the tube body region in the balloon 4, and the rear end of the first tube body 11 is fixed.
  • the outer wall of the second tubular body 12 is fixedly coupled to the balloon 4, the cross section between the first tubular body 11 and the second tubular body 12 oppositely constitutes the communication passage 13, and the communication passage 13 serves as a communicating structure for the conduit 1
  • the cavity is in communication with the lumen of the balloon 4.
  • the rear end of the second guide wire 22 extends into the interior of the first tubular body 11 along the axis of the catheter 1, and the insertion depth of the second guide wire 22 into the first tubular body 11 is greater than that in the balloon. 4, the separation distance between the first tube body 11 and the second tube body 12 when inflated, when the second tube body 12 is longitudinally displaced forward, the second guide wire 22 is displaced longitudinally forward together, the first tube
  • the body 11 is now displaced relatively rearward along the axis of the catheter 1, since the second guide wire 22 extends from the inside of the second tubular body 12 to the inside of the first tubular body 11, and the second guide wire 22 is inserted into the first tubular body 11
  • the insertion depth is greater than the separation distance between the first tube 11 and the second tube 12 when the balloon 4 is inflated, which ensures that the entire catheter does not bend and deform at the cross section of the catheter, and provides good connection and guidance. effect.
  • the catheter 1 since the catheter 1 is divided into two sections in the region of the balloon 4, during the infusion, the balloon 4 expands outward while longitudinally elongating, and the second tube 12 can follow The longitudinal displacement is longitudinally, so that the balloon 4 can not be bent due to the deformation of the catheter.
  • the balloon 4 After the balloon 4 is inserted into a narrow tube or cavity such as a human ureter, the balloon can be expanded evenly to make the narrow tube The sides of the body or cavity are evenly stressed.
  • the separation design of the two-stage catheter avoids the prior art catheter 1 as a whole.
  • the catheter 1 When the balloon 4 is expanded longitudinally, the catheter 1 is longitudinally stretched and deformed. Due to the different materials of the catheter 1 and the balloon 4, the catheter 1 is different.
  • the deformation of the balloon will cause the balloon to be deformed and deformed, resulting in uneven expansion of the surface of the balloon 4, which causes the narrow body of the body to be expanded or the sidewalls of the cavity to be unevenly applied, resulting in the diagnosis and treatment effect. Poor, causing more discomfort to the patient.
  • the second guide wire 22 is inserted into the first tube body 11, and the insertion depth of the second guide wire 22 into the first tube body 11 is greater than between the first tube body 11 and the second tube body 12 when the balloon 4 is inflated. Separation distance. It can be ensured that the second guide wire 22 does not escape from the first tubular body 11 when the balloon 4 is inflated, so that the first tubular body 11 and the second tubular body 12 remain substantially in the conduit 1 when separated. On the axis, it further ensures that the balloon 4 does not bend and deform when it expands, so that the narrow tube body or the side walls of the cavity that need to be expanded are more evenly stressed, and the effect of diagnosis and treatment is greatly improved.
  • the communication passage 13 can communicate with the lumen of the catheter 1 and the lumen of the balloon 4 as a communication structure, so that the guide lumen and the injection lumen can share the same catheter lumen, which greatly reduces the expansion balloon of the embodiment.
  • the diameter of the catheter so that the dilatation balloon catheter of the present embodiment can be inserted into the narrow lumen or cavity of the human body through the instrument channel of the endoscope to realize visualization operation; and the balloon 4 can be prevented from bending during the inflation of the liquid. Deformation has a good therapeutic effect.
  • One or more through holes 14 are also formed in the wall of the first pipe body 11 of the balloon 4, and the through holes 14 are connected as a connecting structure.
  • the first body 11 cavity and the inner cavity of the balloon 4 are passed through.
  • the through hole 14 is disposed between the end portion of the second guide wire 22 inserted into the first tube body 11 and the junction of the first tube body 11 and the balloon 4, that is, the through hole 14 is disposed at the second guide wire 22
  • the end of the first tubular body 11 is adjacent to the side of the operation portion 3.
  • the through hole 14 can communicate the catheter 1 cavity and the balloon 4 as a communication structure, so that the guide wire cavity and the injection cavity can share the same catheter cavity, which greatly reduces the dilatation balloon catheter of the embodiment. diameter of.
  • the first guide wire 21 is drawn out by the insertion and extraction structure connected to the operation portion 3, the first guide wire 21 and the second guide wire 22 do not block the through hole 14 . Can greatly speed up the expansion of the liquid injection.
  • a developing ring 5 is provided at a position where the front end of the balloon 4 is connected to the second tube body 12.
  • the instrument passage of the endoscope in order to determine that the balloon 4 is in the
  • the exact position of the inside of the body or the cavity of the human body can be determined by X-ray imaging technology using the developing ring to monitor the position of the balloon 4 in the body or cavity of the human body, thereby monitoring the position of the body or the inside of the cavity. To achieve the purpose of diagnosis and treatment.
  • a person skilled in the art can also provide a second developing ring (not shown) at the rear end of the balloon 4 and the catheter 1 as needed, and the two developing rings can be arranged by X-ray imaging. The technique more clearly determines the position of the balloon 4 within the body or lumen of the body.
  • the second guide wire 22 is fixedly connected to the inner side of the developing ring 5 by a fixing process, and the fixing process includes glue fixing or hot-melt fixing, and other fixing structures or fixing components may be used to fix the two. .
  • the inside of the conduit of the covering area of the developing ring 5 is closed, so that the injected liquid cannot enter the front of the developing ring, and can only stay inside the balloon behind the developing ring 5, thereby speeding up the filling speed, thereby further shortening The time of surgery.
  • the material of the conduit between the developing ring 5 and the operating portion 3 can be generally made of PEEK, or a material such as nylon or polyamine, preferably a PEEK material; the PEEK material has the advantages of fine diameter and good rigidity, so that The size of the conduit behind the developing ring can be 0.6 to 1.5 mm, preferably 0.7 to 1.0 mm, and most preferably 0.8 mm; the Shore hardness of the catheter can be 50D to 95D; preferably 80D to 90D.
  • the use of PEEK material can further reduce the diameter of the catheter while ensuring the guiding effect of the catheter, thereby improving the diagnosis and treatment and reducing the suffering of the patient.
  • a side of the catheter 1 remote from the operating portion 3 may be provided with a tip catheter 23, the second guide wire 22 extending into the tip catheter 23, the leading end of the tip catheter 23 exceeding the top of the second guide wire 22 0.5 mm - 2 mm, that is, the distance from the end of the tip wire guide 23 to the tip end of the tip end of the developing ring 23 is 0.5 mm - 2 mm.
  • the material of the tip end tube 23 is A soft polymer material is preferably TPU.
  • Will The tip catheter 23 is made of a soft material, which prevents the insertion of the hard material into the inner wall of the ureter, and improves the probability of successful operation.
  • the tip catheter 23 since the tip catheter 23 further includes a part of the second guide wire 22, it has a certain rigidity and can guide.
  • the catheter is inserted into the body.
  • the front end of the tip catheter 23 exceeds the length of the top of the guide wire in the range of 0.5 mm to 2 mm. If the length is less than 0.5 mm, the second guide wire 22 is easy to puncture the tip of the catheter during insertion. If the length is greater than 2 mm, the front end of the catheter may be too It is too soft to be inserted, so the length of 0.5 mm - 2 mm is a suitable range.
  • the end portion of the tip catheter 23 may be provided as a spherical body structure, and the smooth spherical design of the spherical body structure can guide the catheter to be inserted into the elongated catheter inside the human body to be inserted into the body body or the wall surface of the cavity.
  • a scale line is further disposed on the outer circumferential surface of the catheter 1 at the rear end of the balloon 4, and the scale line may be an equidistant scale line, which can be developed by an endoscope. Observing the insertion depth of the balloon 4, it is conventional to determine the position of the balloon by X-ray to determine the position of the balloon. Therefore, in the embodiment of the present invention, only one developing ring 5 can be provided as a spare. Generally, the endoscope development and the scale are used to determine the position, and the X-ray can be assisted by the developing ring 5 only when the scale line is not clear. Determine the exact location of the catheter insertion.
  • the outer wall of the catheter 1 in front of the operating portion 3 is provided with a scale mark, such as 60 cm, 80 cm and 100 cm as shown in FIG. 1 , for identifying the distance of the catheter into the internal cavity of the human body, and the operator can intuitively mark by the scale. The length of catheter insertion was observed.
  • the guide wire 2 of the present embodiment is a metal guide wire
  • the metal guide wire may be a metal material such as a nickel-titanium alloy or a stainless steel, and more preferably a nickel-titanium alloy.
  • Nickel-titanium alloy is a shape memory alloy, which is a special alloy that can automatically restore its plastic deformation to its original shape at a certain temperature. Its expansion rate is above 20%, the fatigue life is up to 1*10, the damping power is 10 times higher than that of ordinary springs, and its corrosion resistance is better than the best medical stainless steel at present, so it can meet various engineering and Medical application needs are a very good functional material.
  • memory alloys are also resistant to wear, corrosion, high damping and superelasticity. The use of nickel-titanium alloy as a metal guide wire can greatly extend the service life of the instrument and reduce the loss rate of the instrument.
  • the operation portion 3 of the dilatation balloon catheter of the present embodiment includes a hand portion 31 that is bored inside the hand portion 31 to form an injection liquid passage that communicates with the lumen of the balloon 4.
  • the design of the hand piece 31 is convenient for the operator to hold the operation.
  • the hand-held portion 31 has a conical structure, that is, a shape body in which the hand-held portion 31 gradually decreases in diameter from the front end of the rear end phase as shown in the drawing, and the design of the conical structure
  • the ergonomic design makes it easier and more comfortable for the operator to hold the expanded balloon catheter for operation. It is conceivable to those skilled in the art that the shape of the hand-held portion 31 is not limited to the shape of a cone as exemplified in the embodiment, and may be other Shape design for easy hand-held operation.
  • a two-way cock 32 is disposed at the rear end of the hand-held portion 31.
  • the plug of the two-way cock 32 is provided with a cocking through hole, and the plug of the two-way cock is rotated.
  • the cocking hole is coaxial with the nozzle of the pipe 1
  • the liquid passage can be opened; when the plug through hole is perpendicular to the nozzle of the conduit 1, the liquid passage can be closed.
  • the two-way cock 32 is fixed to the rear end of the hand-held portion by a nut, and the syringe is connected to the two-way cock 32.
  • the phase-cavity chamber can be passed through the syringe. Injecting liquid into the body.
  • the syringe can be used with a water pump of 20 atmospheres.
  • the rotary two-way cock closes the liquid passage, it can prevent external pollutants, dust, etc. from entering the ureter through the catheter 1, causing the ureter inner wall membrane.
  • the expansion pressure can be maintained to prevent the fluid in the balloon 4 from flowing out, so that the shape of the balloon 4 is stabilized.
  • the design of the two-way cock 32 is compared with the existing injection structure, because the existing injection structure needs to be controlled by the push-pull of the handle or other structure to control the opening or closing of the injection inlet, and the connection between the handle and the catheter is non-fixed.
  • the handle is continuously pushed and pulled, the handle is easily damaged; and the two-way duct 32 of the present invention performs opening and closing of the liquid passage by the action of rotation, has a simple structure, is easy to operate, and prolongs the service life of the instrument.
  • the ends of the hand-held portion 31 and the two-way cock 32 are standard null interfaces and can be used for an external syringe such as a water injection pump.
  • the Null interface is highly versatile and can be configured with different appliances.
  • the rear end of the operating portion 3 is further provided with an external thread 33, and the external thread 33 can be sleeved with the screw cap 35, and the screw cap is connected as a plugging structure to the rear end of the first guide wire 21, so that the operation is performed during the operation.
  • the screw cap 32 can be screwed to drive the first guide wire 21 to move outward, thereby pulling out the first guide wire; or after inserting the first guide wire, screw the screw cap 35 to fix it to the external thread 33.
  • the plug-in structure of the first guide wire 21 is not limited to the screw cap provided by the embodiment, and includes other plug-in structures that can achieve the same function.
  • the operation portion 3 further includes a stress diffusion pipe 34 which is provided at the front end of the hand portion 31, and the pipe 1 is bored inside the stress diffusion pipe 34. Its function is to prevent the stress of the catheter 1 from being excessively damaged from the base, and also to improve the operator's operating feeling and prevent cost loss caused by instrument wear.
  • the stress diffusion tube has a cylindrical shape or a hollow hollow shape inside, and the conical shape has a rearward and outward outer diameter gradually reduced, and can smoothly connect with the hand portion 31 in a shape, the force is more uniform, and the appearance is more beautiful. .
  • a second embodiment of the present invention discloses an expanded balloon catheter comprising a guide wire 2 penetrating inside the catheter 1.
  • the catheter 1 is fixedly coupled to the operation portion 3 at one end thereof, and has a distal end of the catheter 1 away from the operation portion 3
  • the balloon 4, the lumen of the catheter 1 and the lumen of the balloon 4 are communicated by a communication structure disposed on the catheter 1, and the guide wire 2 includes a first guide wire 21 and a second guide wire 22 which are separated from each other, and the first guide wire 21
  • the rear end is connected to the insertion and extraction structure at the rear end of the operation portion 3, and the second guide wire 22 is fixed
  • the process is fixed inside the conduit 1.
  • This embodiment is a modification of the first embodiment.
  • the present embodiment is different from the first embodiment in that a catheter 1 is provided with a tip catheter 23 away from the side of the operation portion 3, and a second The guide wire 22 extends away from the operating portion 3 to the outside of the tip catheter 23, and the portion of the second guide wire 22 that is outside the tip catheter 23 is provided as a spherical body structure 6, that is, the head of the second guide wire 22 is welded or integrally formed into a spheroid Structure 6, that is, forming a guide wire with a ball head.
  • the guide wire 2 is a metal guide wire
  • the metal guide wire may be a metal material such as a nickel titanium alloy or a stainless steel, and more preferably a nickel titanium alloy.
  • Nickel-titanium alloy is a shape memory alloy, which is a special alloy that can automatically restore its plastic deformation to its original shape at a certain temperature.
  • the dilatation balloon catheter of the present invention comprises a first guide wire and a second guide wire separated from each other, and the first guide wire can be inserted and removed through the opening at the rear end of the catheter, thereby causing the guide wire lumen and the injection.
  • the liquid chamber can share the same catheter cavity, no need to additionally set the injection cavity, or it is not necessary to provide a protective film on the surface of the guide wire to protect the guide wire, thus greatly reducing the diameter of the expanded balloon catheter of the present invention, thereby
  • the expandable balloon catheter of the present invention can be inserted into the narrow tube body or cavity of the human body through the instrument channel of the endoscope to realize visual operation, and has good practical value.
  • the dilatation balloon catheter according to the present invention can be used for urinary system (ureter), digestive system (biliary duct, pancreatic duct) respiratory system (airway), and the expansion of the human body stenosis, but is not limited thereto, and the expansion ball according to the present invention
  • the balloon catheter can also be used as a occlusion device.
  • the front end of the catheter 1 is inserted from the gap between the ureter wall and the stone, and when the stone reaches the upstream of the stone or even reaches the large renal pelvic cavity, the first step can be pulled out from the opening at the rear end of the catheter.
  • a guide wire is used as a liquid injection cavity to inject physiological saline, so that the balloon 4 entering the upper part of the stone or the renal pelvic cavity is expanded, and is expanded and blocked in the ureteral cavity upstream of the stone, so that the downstream stone fragments and the flushing liquid cannot enter.
  • the renal pelvis cavity prevents the ureteral lithotripsy from escaping; or after the balloon of the renal pelvic cavity is dilated, the proximal end of the catheter 1 is properly pulled and the renal pelvis outlet at the junction of the renal pelvis and ureter is blocked, so that any ureter stones, stone fragments, and rinsing liquid Can not enter the renal pelvic cavity, and then the treatment of ureteral stones, such as laser fiber lithotripsy, after the stone treatment is completed The liquid in the balloon, then Pull out the catheter.
  • the balloon can be expanded multiple times to adjust the size of the balloon, so that the balloon fits better with the inner wall of the ureter, tightly seals the ureteral calculi, prevents the ureteral stone from escaping, facilitates the operation, and improves the success rate of the stone. .

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Abstract

A dilatable balloon catheter comprises guide wires (2) penetrating in the catheter (1). An operation portion (3) is fixedly connected to one end of the catheter (1). A balloon (4) is disposed in the outer side of the far end of the catheter (1) distant from the operation portion (3). A cavity of the catheter (1) and an inner cavity of the balloon (4) are in communication by means of a communication structure disposed on the catheter (1). The guide wires (2) comprise a first guide wire (21) and a second guide wire (22) separated from each other. The rear end of the first guide wire (21) is connected to a pluggable structure at the rear end of the operation portion (3), and the second guide wire (22) is fixed in the catheter (1) by means of a fixing technology. The guide wires (2) in the balloon dilatation catheter and a liquid injection cavity can share a cavity, and the diameter of the catheter (1) is greatly decreased, so that the dilatable balloon catheter can be inserted into a narrow tube or cavity needing to be dilated in a human body through an endoscopic instrument channel, and visualized operations are achieved.

Description

一种扩张球囊导管Expanded balloon catheter 技术领域Technical field
本发明涉及医疗器械领域，尤其是涉及一种扩张球囊导管。The present invention relates to the field of medical devices, and more particularly to an expanded balloon catheter.
背景技术Background technique
现有技术的扩张球囊导管，例如申请号为CN201520474689.1的实用新型涉及一种用于碎石术的封堵器,所述封堵器包括单向阀门开关、导管、手柄、封堵球囊、保护膜、金属导引导丝、小孔；所述的封堵球囊包裹在导管外表面，与导管形成一个封闭的囊腔，囊腔直径5-25mm；所述封堵球囊呈椭圆形或球形，长度为0.5-5cm；所述封堵球囊包裹的导管上设有小孔；所述导管远端端部固定连接有金属导引导丝；所述金属导引导丝被保护膜所包裹；所述导管近端固定连接手柄；所述手柄上设有条纹；所述单向阀门开关连接在导管近端端部；所述的单向阀门开关设有阀片；所述的单向阀门开关连接注射器或充气阀。该实用新型的用于碎石术的封堵器，所述封堵球囊包裹的导管上设有小孔，封堵球囊和导管内腔通过该小孔相互连通，液体可注入导管内腔继而进入封堵球囊来对球囊进行扩充，然而，该实用新型的封堵球囊在注水膨胀纵向伸长时，导管也变纵向拉伸形变，由于两者材质不一样，导管的形变会使得注水的球囊弯曲变形，这样会导致球囊肿胀时表面的撑开力不均匀，增加手术难度，降低手术治疗效果，且容易造成器械损伤。A prior art expanded balloon catheter, such as the application number CN201520474689.1, relates to an occluder for use in lithotripsy, the occluder comprising a one-way valve switch, a catheter, a handle, a sealing ball a capsule, a protective film, a metal guide wire, a small hole; the occlusion balloon is wrapped on the outer surface of the catheter, and forms a closed capsule with the catheter, the diameter of the capsule is 5-25 mm; the occlusion balloon is elliptical a shape or a spherical shape having a length of 0.5 to 5 cm; a small hole is formed in the catheter wrapped around the balloon; a distal end of the catheter is fixedly connected with a metal guide wire; and the metal guide wire is protected by a protective film. a proximal end of the catheter is fixedly connected to the handle; the handle is provided with a stripe; the one-way valve switch is connected at a proximal end of the catheter; the one-way valve switch is provided with a valve piece; The valve switch is connected to a syringe or inflation valve. In the occluder for the lithotripsy, the catheter that is enclosed by the balloon is provided with a small hole, and the occlusion balloon and the lumen of the catheter communicate with each other through the small hole, and the liquid can be injected into the lumen of the catheter. Then enter the occlusion balloon to expand the balloon. However, when the occlusion balloon of the utility model is longitudinally elongated in the water injection expansion, the catheter also becomes longitudinally stretched and deformed, and the deformation of the catheter is different due to the different materials. The water-injected balloon is bent and deformed, which causes uneven expansion of the surface when the balloon is swollen, increases the difficulty of surgery, reduces the surgical treatment effect, and easily causes damage to the instrument.
申请号为CN201510809012.3的发明提供了一种输尿管结石移动封堵装置，它由导管(1)、可扩张压缩气囊(2)和阀门(3)构成，导管(1)为具有弹性的中空长管状结构，由具有弹性的硅胶或乳胶材料制成，导管(1)的前端设置有开口，该开口位于可扩张压缩气囊(2)的气囊内；可扩张压缩气囊(2)设置在导管(1)的前端，其扩张状态为椭球体状；阀门(3)位于导管(1)的末端，其上设置有注射器接入口(4)。该装置的导管(1)的前段能够通过操作腔进入输尿管使气囊(2)相对固定于结石的上游输尿管腔内或者肾盂出口处，实现了阻断注水水流对肾脏的充盈扩张破坏作用，同时完全阻断了任何结石可能移位或者逃逸到肾盂的通路。该发明的导管(1)的前端设置有开口，该开口位于可扩张压缩气囊(2)的气囊内；可扩张压缩气囊(2)设置在导管(1)的前端，这样的折这使得引导导丝无法设 置于压缩气囊前端，从而无法通过引导导丝起到安全引导和标志作用，从而容易引起输尿管损伤，降低手术成功率。The invention of application No. CN201510809012.3 provides a ureteral stone movement blocking device which is composed of a catheter (1), an expandable compression airbag (2) and a valve (3), and the catheter (1) has a flexible hollow length. The tubular structure is made of elastic silicone or latex material, and the front end of the catheter (1) is provided with an opening in the airbag of the expandable compression airbag (2); the expandable compression airbag (2) is arranged in the catheter (1) The front end of the tube has an expanded state of an ellipsoid shape; the valve (3) is located at the end of the catheter (1) and is provided with a syringe inlet (4). The anterior segment of the catheter (1) of the device can enter the ureter through the operating cavity to fix the balloon (2) relative to the upper ureteral lumen of the stone or the outlet of the renal pelvis, thereby realizing the function of blocking the filling and watering of the water to the kidney, and completely Blocks any pathway in which stones may shift or escape to the renal pelvis. The front end of the catheter (1) of the invention is provided with an opening in the airbag of the expandable compression airbag (2); the expandable compression airbag (2) is disposed at the front end of the catheter (1), such a folding guide guide Silk can't be set It is placed at the front end of the compression airbag, so that it can not be safely guided and marked by guiding the guide wire, thereby easily causing damage to the ureter and reducing the success rate of the operation.
申请号为CN201120001866.6的实用新型公开了一种带有气囊的输尿管导管，包括：管体和气囊，其中：气囊位于管体外侧；管体的两端通透，且其壁上被气囊中的区域内设置有通孔；管体内设置有挡流板，挡流板将管体内的空间分成两个相互独立的腔，分别为注水腔和导丝腔，其中注水腔与通孔相连通，且一端设有开口，另一端封闭，导丝腔两端通透。该实用新型通过挡流板将管体内的空间分成两个相互独立的腔，分别为注水腔和导丝腔，由于挡流板是平行于输尿管导管的轴向而设，两个独立的腔各自需要的管径空间会增加导管的直径，从而使得导管的直径加粗，不利于导管自器械通道伸入人体，也会进一步增加患者的痛苦。The utility model of the application No. CN201120001866.6 discloses a ureteral catheter with a balloon, comprising: a tube body and an air bag, wherein: the air bag is located outside the tube body; both ends of the tube body are transparent, and the wall is in the air bag A through hole is arranged in the area; a baffle is arranged in the tube body, and the baffle divides the space inside the tube into two mutually independent cavities, respectively a water injection chamber and a guide wire cavity, wherein the water injection cavity is connected with the through hole. One end is provided with an opening, the other end is closed, and both ends of the guide wire cavity are transparent. The utility model divides the space inside the tube body into two mutually independent cavities through the baffle, which are respectively a water injection chamber and a guide wire cavity, and the two different cavities are respectively arranged because the baffle plate is parallel to the axial direction of the ureteral catheter. The required diameter of the tube increases the diameter of the catheter, which makes the diameter of the catheter thicker, which is not conducive to the catheter from the device channel into the human body, and further increases the suffering of the patient.
上述现有技术的扩张球囊导管受直径所限无法***内窥镜的器械管道，也容易引起患者在治疗过程中的不适，提高了手术操作的难度，并且在气囊在注水膨胀纵向伸长时，容易弯曲变形，从而降低手术治疗效果，容易造成器械损伤。The above-mentioned prior art dilatation balloon catheter is limited by the diameter of the instrument tube which cannot be inserted into the endoscope, and is also prone to cause discomfort to the patient during the treatment process, which improves the difficulty of the operation operation, and when the airbag is longitudinally elongated in the water injection expansion. It is easy to bend and deform, thus reducing the effect of surgical treatment and easily causing damage to the instrument.
发明内容Summary of the invention
本发明公开一种扩张球囊导管，包括导管和穿设于导管内部的导丝，导管一端固定连接有操作部，在远离操作部的导管的远端外侧包覆有球囊，导管腔体和球囊内腔由设置在导管上的连通结构相连通，导丝包括在球囊内腔内相互分离的第一导丝和第二导丝，第一导丝的后端连接于操作部的插拔结构，第二导丝通过固定工艺固定于导管的另一端。The invention discloses an expanded balloon catheter, comprising a catheter and a guide wire extending through the inside of the catheter. The catheter is fixedly connected with an operation portion at one end, and the balloon is covered on the outer side of the distal end of the catheter remote from the operation portion. And the balloon lumen is communicated by a communication structure disposed on the catheter, the guide wire comprising a first guide wire and a second guide wire separated from each other in the balloon lumen, the rear end of the first guide wire being connected to the operation portion The insertion and removal structure is fixed to the other end of the catheter by a fixing process.
优选地，导管在球囊中的管体区域相互分离为第一管体和第二管体，第一管体的后端固定连接于操作部，第二管体的外壁固定连接于球囊，第一管体和第二管体之间的断面相对构成一连通通道，连通通道作为连通结构将导管腔体和球囊内腔相连通，第二导丝***第一管体内的***深度大于在球囊4膨胀时第一管体和第二管体之间的分离距离。Preferably, the tube body is separated from the tube body region in the balloon into a first tube body and a second tube body, the rear end of the first tube body is fixedly connected to the operation portion, and the outer wall of the second tube body is fixedly connected to the balloon. The cross section between the first tube body and the second tube body constitutes a communication channel, and the communication channel serves as a communication structure to connect the catheter cavity and the balloon lumen, and the insertion depth of the second guide wire into the first tube body is greater than The separation distance between the first tube body and the second tube body when the balloon 4 is inflated.
进一步地，球囊中的导管的管壁上设有一个或多个通孔，通孔作为连通结构连通导管腔体和球囊内腔，通孔14设置在第二导丝***第一管体内的端部和第一管体与球囊的连接处之间。Further, one or more through holes are provided in the tube wall of the catheter in the balloon, the through hole serves as a communication structure to communicate the catheter cavity and the balloon lumen, and the through hole 14 is disposed in the second guide wire to be inserted into the first tube The end of the body and the junction of the first tube and the balloon.
优选地，球囊前端与第二管体的相连接之处设有显影环，显影环中区域的导管的内部封闭。Preferably, a developing ring is provided at a position where the front end of the balloon is connected to the second pipe body, and the inside of the duct in the region in the developing ring is closed.
优选地，导管远离操作部的一侧设置尖端导管，第二导丝延伸至尖端导管内，第二导丝位于尖端导管中的端部与尖端导管顶端的距离为0.5mm-2mm。 Preferably, the catheter is provided with a tip catheter away from the side of the operating portion, the second guide wire extending into the tip catheter, the end of the second guide wire in the tip catheter being at a distance of 0.5 mm to 2 mm from the tip end of the tip catheter.
优选地，导管远离操作部的一侧设置尖端导管，第二导丝远离操作部延伸至尖端导管的外部，第二导丝的位于尖端导管外部的部分设置为球状体结构。Preferably, the catheter is provided with a tip catheter away from the side of the operating portion, the second guide wire extends away from the operating portion to the outside of the tip catheter, and the portion of the second guide wire that is external to the tip catheter is configured as a spherical body structure.
优选地，操作部包括手持部，导管穿设于手持部内部，形成连通于球囊内腔的液体通道。Preferably, the operating portion includes a hand-held portion, and the catheter is disposed inside the hand-held portion to form a liquid passage that communicates with the inner cavity of the balloon.
进一步地，手持部的后端设有二通旋塞，二通旋塞的塞子上设置有旋塞通孔，当旋塞通孔与导管的管口同轴时，打开液体通道；当旋塞通孔与导管的管口垂直时，关闭液体通道。Further, a rear end of the hand-held portion is provided with a two-way cock, and a plug of the two-way cock is provided with a cocking through hole. When the cocking hole is coaxial with the pipe of the pipe, the liquid passage is opened; when the cocking hole and the pipe are When the nozzle is vertical, close the liquid passage.
优选地，在球囊后端的导管外周面上设有刻度线。Preferably, a scale line is provided on the outer peripheral surface of the catheter at the rear end of the balloon.
进一步地，操作部的后端设有外螺纹，外螺纹可套接螺丝帽，螺丝帽作为插拔结构与第一导丝的后端相连接，可通过拆卸螺丝帽来拔出第一导丝。Further, the rear end of the operating portion is provided with an external thread, the external thread can be sleeved with the screw cap, and the screw cap is connected as the insertion and extraction structure to the rear end of the first guide wire, and the first guide wire can be pulled out by removing the screw cap .
综上所述，本发明的扩张球囊导管，包括相互分离的第一导丝和第二导丝，第一导丝可通过导管后端的开口进行插拔，从而使得导丝腔和注液腔可共用同一个导管腔体，无需另外设置注液腔，或者无需在导丝表面另外设置保护膜对导丝进行保护，如此大大减小了本实施例的扩张球囊导管的直径，从而使得本发明的扩张球囊导管可通过内窥镜的器械通道***人体内需要扩张的狭窄管体或者腔体，实现可视化操作，具有很好的实用价值。In summary, the dilatation balloon catheter of the present invention comprises a first guide wire and a second guide wire separated from each other, and the first guide wire can be inserted and removed through the opening at the rear end of the catheter, thereby making the guide wire cavity and the injection cavity The same catheter cavity can be shared, no need to additionally set the injection cavity, or the protective wire is additionally provided on the surface of the guide wire to protect the guide wire, thus greatly reducing the diameter of the expanded balloon catheter of the embodiment, thereby The dilatation balloon catheter of the present invention can be inserted into the narrow tube body or cavity of the human body through the instrument channel of the endoscope to realize visual operation, and has good practical value.
可用于泌尿***(输尿管)，消化***(胆管，胰管)呼吸***(气道)人体腔道狭窄的扩张。It can be used for urinary system (ureter), digestive system (biliary duct, pancreatic duct) respiratory system (airway) for the narrow expansion of the human body.
为让本发明的上述内容能更明显易懂，下文特举优选实施例，并结合附图，作详细说明如下。In order to make the above description of the present invention more comprehensible, the preferred embodiments will be described below in detail with reference to the accompanying drawings.
附图说明DRAWINGS
下面将结合附图介绍本发明。The invention will now be described with reference to the accompanying drawings.
图1为本发明实施例中的扩张球囊导管的局部结构示意图；1 is a partial structural view showing an expanded balloon catheter in an embodiment of the present invention;
图2为本发明实施例中的扩张球囊导管的另一局部结构示意图；2 is a schematic view showing another partial structure of an expanded balloon catheter according to an embodiment of the present invention;
图3为本发明实施例中的扩张球囊导管的整体结构示意图。3 is a schematic view showing the overall structure of an expanded balloon catheter in an embodiment of the present invention.
具体实施方式Detailed ways
以下由特定的具体实施例说明本发明的实施方式，本领域技术人员可由本说明书所揭 示的内容轻易地了解本发明的其他优点及功效。The embodiments of the present invention are described below by specific embodiments, and those skilled in the art may disclose the present disclosure. The other contents and effects of the present invention are readily understood by the contents shown.
现在参考附图介绍本发明的示例性实施方式，然而，本发明可以用许多不同的形式来实施，并且不局限于此处描述的实施例，提供这些实施例是为了详尽地且完全地公开本发明，并且向所属技术领域的技术人员充分传达本发明的范围。对于表示在附图中的示例性实施方式中的术语并不是对本发明的限定。在附图中，相同的单元/元件使用相同的附图标记。The exemplary embodiments of the present invention are now described with reference to the drawings, however, the present invention may be embodied in many different forms and not limited to the embodiments described herein. The invention is fully disclosed to those skilled in the art. The terms used in the exemplary embodiments shown in the drawings are not intended to limit the invention. In the figures, the same elements/elements are given the same reference numerals.
除非另有说明，此处使用的术语(包括科技术语)对所属技术领域的技术人员具有通常的理解含义。另外，可以理解的是，以通常使用的词典限定的术语，应当被理解为与其相关领域的语境具有一致的含义，而不应该被理解为理想化的或过于正式的意义。Unless otherwise stated, the terms (including technical and scientific terms) used herein have the ordinary meaning of meaning to those skilled in the art. In addition, it is to be understood that terms defined in commonly used dictionaries should be understood as having a meaning consistent with the context of the relevant art, and should not be construed as an idealized or overly formal meaning.
第一实施例First embodiment
如图1所示，本发明第一实施例公开了一种扩张球囊导管，包括穿设于导管1和导管1内部的导丝2，导管1一端固定连接有操作部3，在远离操作部3的导管1的远端外侧中有一球囊4，导管1的腔体和球囊4的内腔之间由设置在导管1上的连通结构相连通，其中，导丝2包括相互分离的第一导丝21和第二导丝22，第一导丝21的后端通过插拔结构可插拔地连接于操作部3上，第二导丝22通过固定工艺固定于导管1的另一端。As shown in FIG. 1 , a first embodiment of the present invention discloses an expansion balloon catheter including a guide wire 2 that is disposed inside the catheter 1 and the catheter 1 . The catheter 1 is fixedly connected to the operation portion 3 at one end thereof, away from the operation portion. 3 has a balloon 4 in the distal outer side of the catheter 1, and the lumen of the catheter 1 and the lumen of the balloon 4 are connected by a communication structure disposed on the catheter 1, wherein the guide wire 2 includes a separation from each other. A guide wire 21 and a second guide wire 22, the rear end of the first guide wire 21 is detachably connected to the operation portion 3 by a plug-in structure, and the second guide wire 22 is fixed to the other end of the catheter 1 by a fixing process.
导丝2包括相互分离的第一导丝21和第二导丝22，第一导丝21可通过操作部3上设置的插拔结构进行插拔，扩张球囊导管***人体时，第一导丝21可通过操作部3上设置插拔结构***导管腔体，导管腔体作为导丝腔穿设导丝，利用导丝进行引导***，注液时便可将第一导丝21拔出，将导管腔体作为注液腔来注入液体，从而使得导丝腔和注液腔可共用同一个导管腔体，无需另外设置注液腔，或者无需在导丝表面另外设置保护膜对导丝进行保护，如此一来，大大减小了本实施例的扩张球囊导管的直径，从而使得本实施例的扩张球囊导管可通过内窥镜的器械通道***人体内需要扩张的狭窄管体或者腔体人体内，实现可视化操作。The guide wire 2 includes a first guide wire 21 and a second guide wire 22 which are separated from each other. The first guide wire 21 can be inserted and removed through the insertion and extraction structure provided on the operation portion 3, and the first guide wire is inserted into the human body when the balloon catheter is inserted into the human body. The wire 21 can be inserted into the catheter cavity through the insertion and extraction structure on the operation portion 3, the catheter cavity is used as a guide wire cavity to guide the guide wire, and the guide wire is used for guiding insertion. When the liquid is injected, the first guide wire 21 can be pulled out. Out, the catheter cavity is injected as a liquid injection cavity, so that the guide wire cavity and the injection cavity can share the same catheter cavity, no additional injection cavity is required, or a protective film is not required on the surface of the guide wire. The guide wire is protected, so that the diameter of the expanded balloon catheter of the embodiment is greatly reduced, so that the expanded balloon catheter of the embodiment can be inserted into the human body through the instrument channel of the endoscope. Visualization is performed in the body or cavity body.
其中，注入球囊的液体优选为生理盐水，当向导管内部注射生理盐水时，生理盐水由导管1后端进入，因导管1前端为封闭结构，生理盐水自设置于导管上的连通结构流出并蓄积在球囊4中，使得球囊4向外膨胀扩张，当从导管内部抽出生理盐水时，球囊4收缩回原始状态。Wherein, the liquid injected into the balloon is preferably physiological saline. When the physiological saline is injected into the catheter, the physiological saline enters from the rear end of the catheter 1 because the front end of the catheter 1 is a closed structure, and the physiological saline flows out from the communicating structure provided on the catheter and Accumulated in the balloon 4, the balloon 4 is expanded and expanded outward, and when the physiological saline is withdrawn from the inside of the catheter, the balloon 4 is contracted back to the original state.
其中，导管1内部为中空结构，且导管1的前端为封闭结构，导管1的后端为开口结构，导管1内部穿设引导导丝2，导管1腔体和球囊4内腔由设置在导管1上的连通结构 相连通。Wherein, the inside of the catheter 1 is a hollow structure, and the front end of the catheter 1 is a closed structure, the rear end of the catheter 1 is an open structure, and the guide wire 2 is disposed inside the catheter 1 , and the lumen of the catheter 1 and the lumen of the balloon 4 are disposed at Connecting structure on the conduit 1 Connected.
具体地，如图1所示，本实施例中，导管1在球囊4中的管体区域中相互分离为第一管体11和第二管体12，第一管体11的后端固定连接于操作部3，第二管体12的外壁固定连接于球囊4，第一管体11和第二管体12之间的断面相对构成连通通道13，连通通道13作为连通结构将导管1腔体和球囊4内腔相连通。Specifically, as shown in FIG. 1, in the present embodiment, the catheter 1 is separated from each other into the first tube body 11 and the second tube body 12 in the tube body region in the balloon 4, and the rear end of the first tube body 11 is fixed. Connected to the operating portion 3, the outer wall of the second tubular body 12 is fixedly coupled to the balloon 4, the cross section between the first tubular body 11 and the second tubular body 12 oppositely constitutes the communication passage 13, and the communication passage 13 serves as a communicating structure for the conduit 1 The cavity is in communication with the lumen of the balloon 4.
如图1中所示，第二导丝22的后端沿着导管1的轴线延伸***第一管体11的内部，第二导丝22***第一管体11内的***深度大于在球囊4膨胀时第一管体11和所述第二管体12之间的分离距离，当第二管体12纵向向前位移时，第二导丝22随之一起纵向向前位移，第一管体11此时沿着导管1的轴线相对向后位移，由于第二导丝22自第二管体12内部延伸至第一管体11内部，且第二导丝22***第一管体11内的***深度大于在球囊4膨胀时第一管体11和所述第二管体12之间的分离距离，能够保证导管整体不会在导管的断面处弯曲变形，起到了良好的连接和引导作用。As shown in Fig. 1, the rear end of the second guide wire 22 extends into the interior of the first tubular body 11 along the axis of the catheter 1, and the insertion depth of the second guide wire 22 into the first tubular body 11 is greater than that in the balloon. 4, the separation distance between the first tube body 11 and the second tube body 12 when inflated, when the second tube body 12 is longitudinally displaced forward, the second guide wire 22 is displaced longitudinally forward together, the first tube The body 11 is now displaced relatively rearward along the axis of the catheter 1, since the second guide wire 22 extends from the inside of the second tubular body 12 to the inside of the first tubular body 11, and the second guide wire 22 is inserted into the first tubular body 11 The insertion depth is greater than the separation distance between the first tube 11 and the second tube 12 when the balloon 4 is inflated, which ensures that the entire catheter does not bend and deform at the cross section of the catheter, and provides good connection and guidance. effect.
本实施例中，由于导管1在球囊4所中的区域内分为两段，手术过程中在注液时，球囊4向外膨胀同时纵向伸长，第二管体12也可以随之纵向向前位移，这样可以使得球囊4不会因为导管的拉升形变而弯曲，球囊4在***到诸如人体内输尿管之类的狭窄管体或者腔体后，可扩张均匀，使狭窄管体或者腔体各侧壁受力均匀。两段导管的分离设计避免了现有技术中的导管1为一个整体，在球囊4膨胀纵向伸长时，导管1变纵向拉伸形变，由于导管1和球囊4的材质不同，导管1的形变会使得膨胀后的球囊弯曲变形，导致球囊4扩张时表面的撑开力不均匀，使得人体内需要扩张的狭窄管体或者腔体各侧壁受力不均，造成诊疗的效果不佳，引起患者更多不适。In the present embodiment, since the catheter 1 is divided into two sections in the region of the balloon 4, during the infusion, the balloon 4 expands outward while longitudinally elongating, and the second tube 12 can follow The longitudinal displacement is longitudinally, so that the balloon 4 can not be bent due to the deformation of the catheter. After the balloon 4 is inserted into a narrow tube or cavity such as a human ureter, the balloon can be expanded evenly to make the narrow tube The sides of the body or cavity are evenly stressed. The separation design of the two-stage catheter avoids the prior art catheter 1 as a whole. When the balloon 4 is expanded longitudinally, the catheter 1 is longitudinally stretched and deformed. Due to the different materials of the catheter 1 and the balloon 4, the catheter 1 is different. The deformation of the balloon will cause the balloon to be deformed and deformed, resulting in uneven expansion of the surface of the balloon 4, which causes the narrow body of the body to be expanded or the sidewalls of the cavity to be unevenly applied, resulting in the diagnosis and treatment effect. Poor, causing more discomfort to the patient.
第二导丝22***第一管体11内，第二导丝22***第一管体11内的***深度大于在球囊4膨胀时第一管体11和所述第二管体12之间的分离距离。可以确保在球囊4膨胀时，第二导丝22不会从第一管体11内脱出，从而使得第一管体11和所述第二管体12在分离时基本保持在导管1的中轴线上，进一步确保球囊4膨胀时不会弯曲变形，使得需要扩张的狭窄管体或者腔体各侧壁受力更加均匀，大大提高诊疗的效果。The second guide wire 22 is inserted into the first tube body 11, and the insertion depth of the second guide wire 22 into the first tube body 11 is greater than between the first tube body 11 and the second tube body 12 when the balloon 4 is inflated. Separation distance. It can be ensured that the second guide wire 22 does not escape from the first tubular body 11 when the balloon 4 is inflated, so that the first tubular body 11 and the second tubular body 12 remain substantially in the conduit 1 when separated. On the axis, it further ensures that the balloon 4 does not bend and deform when it expands, so that the narrow tube body or the side walls of the cavity that need to be expanded are more evenly stressed, and the effect of diagnosis and treatment is greatly improved.
连通通道13既可以作为连通结构将导管1腔体和球囊4内腔相连通，使得导丝腔和注液腔可共用同一个导管腔体，大大减小了本实施例的扩张球囊导管的直径，从而使得本实施例的扩张球囊导管可通过内窥镜的器械通道***人体内需要扩张的狭窄管体或者腔体，实现可视化操作；也可以防止气囊4在注液膨胀时弯曲形变，具有很好的治疗效果。The communication passage 13 can communicate with the lumen of the catheter 1 and the lumen of the balloon 4 as a communication structure, so that the guide lumen and the injection lumen can share the same catheter lumen, which greatly reduces the expansion balloon of the embodiment. The diameter of the catheter, so that the dilatation balloon catheter of the present embodiment can be inserted into the narrow lumen or cavity of the human body through the instrument channel of the endoscope to realize visualization operation; and the balloon 4 can be prevented from bending during the inflation of the liquid. Deformation has a good therapeutic effect.
球囊4中的第一管体11的管壁上还设有一个或多个通孔14，通孔14作为连通结构连 通第一管体11腔体和球囊4内腔。通孔14设置在第二导丝22***第一管体11内的端部和第一管体11与球囊4的连接处之间，也就是说通孔14设置在第二导丝22***第一管体11内的端部的靠近操作部3的一侧。One or more through holes 14 are also formed in the wall of the first pipe body 11 of the balloon 4, and the through holes 14 are connected as a connecting structure. The first body 11 cavity and the inner cavity of the balloon 4 are passed through. The through hole 14 is disposed between the end portion of the second guide wire 22 inserted into the first tube body 11 and the junction of the first tube body 11 and the balloon 4, that is, the through hole 14 is disposed at the second guide wire 22 The end of the first tubular body 11 is adjacent to the side of the operation portion 3.
此外，通孔14可作为连通结构将导管1腔体和球囊4相连通，使得导丝腔和注液腔可共用同一个导管腔体，大大减小了本实施例的扩张球囊导管的直径。并且，当第一导丝21通过连接于所述操作部3的插拔结构抽出第一管体11后进行注液时，第一导丝21和第二导丝22均不会阻挡通孔14，可以大大加快注液膨胀的速度。In addition, the through hole 14 can communicate the catheter 1 cavity and the balloon 4 as a communication structure, so that the guide wire cavity and the injection cavity can share the same catheter cavity, which greatly reduces the dilatation balloon catheter of the embodiment. diameter of. Moreover, when the first guide wire 21 is drawn out by the insertion and extraction structure connected to the operation portion 3, the first guide wire 21 and the second guide wire 22 do not block the through hole 14 . Can greatly speed up the expansion of the liquid injection.
优选地，如图1所示，在球囊4前端与第二管体12的相连接之处设有显影环5，在无法利用内窥镜的器械通道的情况下，为了确定球囊4在人体的管体或者腔体内部移动的准确位置，可以利用显影环通过X线造影录像技术确定球囊4在人体的管体或者腔体内的位置，从而监视人体的管体或者腔体内部的位置，达到诊疗的目的。Preferably, as shown in FIG. 1, a developing ring 5 is provided at a position where the front end of the balloon 4 is connected to the second tube body 12. In the case where the instrument passage of the endoscope cannot be utilized, in order to determine that the balloon 4 is in the The exact position of the inside of the body or the cavity of the human body can be determined by X-ray imaging technology using the developing ring to monitor the position of the balloon 4 in the body or cavity of the human body, thereby monitoring the position of the body or the inside of the cavity. To achieve the purpose of diagnosis and treatment.
同样，本领域的技术人员也可以根据需要，在球囊4后端与导管1的相连接之处设有第二显影环(未示出)，两个显影环的设置可以通过X线造影录像技术更清楚的确定球囊4在人体的管体或者腔体内的位置。Similarly, a person skilled in the art can also provide a second developing ring (not shown) at the rear end of the balloon 4 and the catheter 1 as needed, and the two developing rings can be arranged by X-ray imaging. The technique more clearly determines the position of the balloon 4 within the body or lumen of the body.
进一步地，第二导丝22通过固定工艺来固定连接于显影环5的内侧，该固定工艺包括胶水固定或者热熔固定，也可以利用其它的固定结构或者固定元器件来将两者进行固定连接。Further, the second guide wire 22 is fixedly connected to the inner side of the developing ring 5 by a fixing process, and the fixing process includes glue fixing or hot-melt fixing, and other fixing structures or fixing components may be used to fix the two. .
进一步地，显影环5包覆区域的导管的内部封闭，使得注入的液体不能进入显影环的前方，只能停留在显影环5后方的球囊内部，加快了注液的速度，从而进一步缩短了手术的时间。Further, the inside of the conduit of the covering area of the developing ring 5 is closed, so that the injected liquid cannot enter the front of the developing ring, and can only stay inside the balloon behind the developing ring 5, thereby speeding up the filling speed, thereby further shortening The time of surgery.
本实施例中，显影环5与操作部3之间的导管的材料通常可采用PEEK，也可以用尼龙、聚烯胺等材料，优选PEEK材料；PEEK材料具有直径细且刚性佳的优点，使得显影环后方的导管尺寸可达到0.6～1.5毫米，优选为0.7～1.0毫米，最优0.8mm；导管的邵氏硬度可达到50D～95D；优选80D～90D。采用PEEK材料可在保证导管引导作用的同时，进一步减小导管的直径，从而提高诊疗效果，减少患者的痛苦。In this embodiment, the material of the conduit between the developing ring 5 and the operating portion 3 can be generally made of PEEK, or a material such as nylon or polyamine, preferably a PEEK material; the PEEK material has the advantages of fine diameter and good rigidity, so that The size of the conduit behind the developing ring can be 0.6 to 1.5 mm, preferably 0.7 to 1.0 mm, and most preferably 0.8 mm; the Shore hardness of the catheter can be 50D to 95D; preferably 80D to 90D. The use of PEEK material can further reduce the diameter of the catheter while ensuring the guiding effect of the catheter, thereby improving the diagnosis and treatment and reducing the suffering of the patient.
较佳地，如图1所示，导管1远离操作部3的一侧可以设置尖端导管23，第二导丝22延伸至尖端导管23内，该尖端导管23前端超过第二导丝22顶部大约0.5mm-2mm，即第二导丝22位于所述尖端导管23中的端部到显影环前端的尖端导管23顶端的距离为0.5mm-2mm，本发明实施例中，尖端导管23的材质为柔软的高分子材料，优选为TPU。将 尖端导管23采用柔软材质，可以避免坚硬材质***对输尿管内壁造成损伤，提高了手术成功的概率，同时由于尖端导管23内部还包括部分的第二导丝22，使得其具有一定的刚性，能够引导导管***人体内部。其中，尖端导管23前端超过导丝顶部的长度范围为0.5mm-2mm，若长度小于0.5mm，第二导丝22***过程中容易戳破导管顶端，若长度大于2mm，则导管前端会由于太过于柔软而无法***，因此0.5mm-2mm的长度为合适的范围。Preferably, as shown in FIG. 1, a side of the catheter 1 remote from the operating portion 3 may be provided with a tip catheter 23, the second guide wire 22 extending into the tip catheter 23, the leading end of the tip catheter 23 exceeding the top of the second guide wire 22 0.5 mm - 2 mm, that is, the distance from the end of the tip wire guide 23 to the tip end of the tip end of the developing ring 23 is 0.5 mm - 2 mm. In the embodiment of the present invention, the material of the tip end tube 23 is A soft polymer material is preferably TPU. Will The tip catheter 23 is made of a soft material, which prevents the insertion of the hard material into the inner wall of the ureter, and improves the probability of successful operation. At the same time, since the tip catheter 23 further includes a part of the second guide wire 22, it has a certain rigidity and can guide. The catheter is inserted into the body. Wherein, the front end of the tip catheter 23 exceeds the length of the top of the guide wire in the range of 0.5 mm to 2 mm. If the length is less than 0.5 mm, the second guide wire 22 is easy to puncture the tip of the catheter during insertion. If the length is greater than 2 mm, the front end of the catheter may be too It is too soft to be inserted, so the length of 0.5 mm - 2 mm is a suitable range.
进一步地，还可以将上述尖端导管23的端部设置为球状体结构，球状体结构的光滑球面设计能够引导导管***人体内部细长状的导管***对人体内管体或者腔体壁面的损伤。Further, the end portion of the tip catheter 23 may be provided as a spherical body structure, and the smooth spherical design of the spherical body structure can guide the catheter to be inserted into the elongated catheter inside the human body to be inserted into the body body or the wall surface of the cavity.
如图1所示，本发明第一实施例中，在球囊4后端的导管1外周面上还设有刻度线，刻度线可以是等距离的刻度线，这样可以通过内窥镜的显影来观测球囊4的***深度，传统的是通过X射线来确定显影环的位置来确定球囊的位置。因此，本发明实施例中可以只设置有一个显影环5作为备用，通常情况下就利用内窥镜显影和刻度来确定位置，只有在刻度线看不清楚时可利用显影环5辅助X射线来确定导管***的准确位置。As shown in FIG. 1 , in the first embodiment of the present invention, a scale line is further disposed on the outer circumferential surface of the catheter 1 at the rear end of the balloon 4, and the scale line may be an equidistant scale line, which can be developed by an endoscope. Observing the insertion depth of the balloon 4, it is conventional to determine the position of the balloon by X-ray to determine the position of the balloon. Therefore, in the embodiment of the present invention, only one developing ring 5 can be provided as a spare. Generally, the endoscope development and the scale are used to determine the position, and the X-ray can be assisted by the developing ring 5 only when the scale line is not clear. Determine the exact location of the catheter insertion.
较佳地，操作部3前方的导管1外壁上设有刻度标识，如图1中所示的60cm，80cm和100cm，用于标识导管进入人体内部腔道的距离，操作者可通过刻度标识直观地观察到导管***的长度。Preferably, the outer wall of the catheter 1 in front of the operating portion 3 is provided with a scale mark, such as 60 cm, 80 cm and 100 cm as shown in FIG. 1 , for identifying the distance of the catheter into the internal cavity of the human body, and the operator can intuitively mark by the scale. The length of catheter insertion was observed.
优选地，本实施例的导丝2为金属导丝，金属导丝可以用镍钛合金或不锈钢等金属材料，进一步优选为镍钛合金。镍钛合金是一种形状记忆合金，形状记忆合金是能将自身的塑性变形在某一特定温度下自动恢复为原始形状的特种合金。它的伸缩率在20％以上，疲劳寿命达1*10的7次方，阻尼特性比普通的弹簧高10倍，其耐腐蚀性优于目前最好的医用不锈钢，因此可以满足各类工程和医学的应用需求，是一种非常优秀的功能材料。记忆合金除具有独特的形状记忆功能外，还具有耐磨损、抗腐蚀、高阻尼和超弹性等优异特点。利用镍钛合金作为金属导丝，可大大延长器械的使用寿命，降低器械损耗率。Preferably, the guide wire 2 of the present embodiment is a metal guide wire, and the metal guide wire may be a metal material such as a nickel-titanium alloy or a stainless steel, and more preferably a nickel-titanium alloy. Nickel-titanium alloy is a shape memory alloy, which is a special alloy that can automatically restore its plastic deformation to its original shape at a certain temperature. Its expansion rate is above 20%, the fatigue life is up to 1*10, the damping power is 10 times higher than that of ordinary springs, and its corrosion resistance is better than the best medical stainless steel at present, so it can meet various engineering and Medical application needs are a very good functional material. In addition to its unique shape memory function, memory alloys are also resistant to wear, corrosion, high damping and superelasticity. The use of nickel-titanium alloy as a metal guide wire can greatly extend the service life of the instrument and reduce the loss rate of the instrument.
如图3所示，本实施例的扩张球囊导管的操作部3包括手持部31，导管穿设于手持部31的内部，形成连通于球囊4内腔的注射液体通道。手持部31的设计便于手术操作者握持进行操作。进一步地，从图1中可知，手持部31为圆锥状体结构，即如图中所示的手持部31自后端相前端直径逐渐平滑过渡减小的形状体，该圆锥状体结构的设计符合人体工学设计，使得操作者握持扩张球囊导管进行操作时更为方便和舒适。本领域技术人员可以想到的是，该手持部31的形状并不限于本实施例中所列举的圆锥体状，还可以为其他 便于手持操作的形状设计。As shown in FIG. 3, the operation portion 3 of the dilatation balloon catheter of the present embodiment includes a hand portion 31 that is bored inside the hand portion 31 to form an injection liquid passage that communicates with the lumen of the balloon 4. The design of the hand piece 31 is convenient for the operator to hold the operation. Further, as can be seen from FIG. 1, the hand-held portion 31 has a conical structure, that is, a shape body in which the hand-held portion 31 gradually decreases in diameter from the front end of the rear end phase as shown in the drawing, and the design of the conical structure The ergonomic design makes it easier and more comfortable for the operator to hold the expanded balloon catheter for operation. It is conceivable to those skilled in the art that the shape of the hand-held portion 31 is not limited to the shape of a cone as exemplified in the embodiment, and may be other Shape design for easy hand-held operation.
优选地，在手持部31的后端设置由二通旋塞32，二通旋塞32的塞子上设有旋塞通孔，旋转二通旋塞的塞子，当旋塞通孔于导管1的管口同轴时，可打开液体通道；当旋塞通孔于导管1的管口垂直时，可关闭液体通道。如图1中所示，二通旋塞32通过螺帽固定于手持部的后端，在二通旋塞32上连接注射器具，当旋转二通旋塞打开液体通道时，可通过注射器具相导管腔体内部注入液体，实践中，注射器具可实用20个大气压的注水泵；当旋转二通旋塞关闭液体通道时，一方面可防止外界的污染物、粉尘等通过导管1进入输尿管，引起输尿管内壁薄膜感染,另一方面，可保持扩张压力防止球囊4中的液体流出，使得封堵球囊4形状稳定。二通旋塞32的设计与现有的注射结构相比，因现有的注射结构需要通过手柄或其他结构的推拉来控制注射入口的打开或关闭，其手柄与导管间的连接为非固定的，通过不断的推拉手柄时，手柄容易损坏；而本发明的二通导管32是通过旋转的动作来进行液体通道的打开和关闭，结构简单，易于操作，且延长了器械使用寿命。Preferably, a two-way cock 32 is disposed at the rear end of the hand-held portion 31. The plug of the two-way cock 32 is provided with a cocking through hole, and the plug of the two-way cock is rotated. When the cocking hole is coaxial with the nozzle of the pipe 1 The liquid passage can be opened; when the plug through hole is perpendicular to the nozzle of the conduit 1, the liquid passage can be closed. As shown in FIG. 1, the two-way cock 32 is fixed to the rear end of the hand-held portion by a nut, and the syringe is connected to the two-way cock 32. When the two-way cock is opened to open the liquid passage, the phase-cavity chamber can be passed through the syringe. Injecting liquid into the body. In practice, the syringe can be used with a water pump of 20 atmospheres. When the rotary two-way cock closes the liquid passage, it can prevent external pollutants, dust, etc. from entering the ureter through the catheter 1, causing the ureter inner wall membrane. Infection, on the other hand, the expansion pressure can be maintained to prevent the fluid in the balloon 4 from flowing out, so that the shape of the balloon 4 is stabilized. The design of the two-way cock 32 is compared with the existing injection structure, because the existing injection structure needs to be controlled by the push-pull of the handle or other structure to control the opening or closing of the injection inlet, and the connection between the handle and the catheter is non-fixed. When the handle is continuously pushed and pulled, the handle is easily damaged; and the two-way duct 32 of the present invention performs opening and closing of the liquid passage by the action of rotation, has a simple structure, is easy to operate, and prolongs the service life of the instrument.
如图3中所示，手持部31和二通旋塞32的末端均为标准的null接口，可用于外接注水泵等注射器具。Null接口通用性较强，可配置不同的器具。As shown in FIG. 3, the ends of the hand-held portion 31 and the two-way cock 32 are standard null interfaces and can be used for an external syringe such as a water injection pump. The Null interface is highly versatile and can be configured with different appliances.
进一步地，操作部3的后端还设有外螺纹33，外螺纹33可套接螺丝帽35，螺丝帽作为插拔结构与第一导丝21的后端相连接，使得手术过程中，操作者可拧转螺丝帽32来带动第一导丝21外移，从而拔出第一导丝；或者***第一导丝之后，拧转螺丝帽35使之固定于外螺纹33上。本领域技术人员可以想到，第一导丝21的插拔结构不仅仅限于本实施例所提供的螺丝帽，还包括其他可实现相同功能的插拔结构。Further, the rear end of the operating portion 3 is further provided with an external thread 33, and the external thread 33 can be sleeved with the screw cap 35, and the screw cap is connected as a plugging structure to the rear end of the first guide wire 21, so that the operation is performed during the operation. The screw cap 32 can be screwed to drive the first guide wire 21 to move outward, thereby pulling out the first guide wire; or after inserting the first guide wire, screw the screw cap 35 to fix it to the external thread 33. It is conceivable to those skilled in the art that the plug-in structure of the first guide wire 21 is not limited to the screw cap provided by the embodiment, and includes other plug-in structures that can achieve the same function.
如图3所示，操作部3还包括应力扩散管34，应力扩散管34设置在手持部31的前端，导管1穿设于应力扩散管34的内部。其作用是避免导管1从基部处的应力过大而损伤，也提高了操作者的操作手感，防止器械耗损造成的成本损失。应力扩散管为圆筒状或内部中空的圆锥体状，圆锥体状有后向前外径逐渐缩小，能够与手持部31在形状上平滑过渡衔接，受力更为均匀，并且外观更为美观。As shown in FIG. 3, the operation portion 3 further includes a stress diffusion pipe 34 which is provided at the front end of the hand portion 31, and the pipe 1 is bored inside the stress diffusion pipe 34. Its function is to prevent the stress of the catheter 1 from being excessively damaged from the base, and also to improve the operator's operating feeling and prevent cost loss caused by instrument wear. The stress diffusion tube has a cylindrical shape or a hollow hollow shape inside, and the conical shape has a rearward and outward outer diameter gradually reduced, and can smoothly connect with the hand portion 31 in a shape, the force is more uniform, and the appearance is more beautiful. .
第二实施例Second embodiment
本发明第二实施例公开一种扩张球囊导管，包括穿设于导管1内部的导丝2，导管1一端固定连接有操作部3，在远离操作部3的导管1的远端外侧中有一球囊4，导管1腔体和球囊4内腔由设置在导管1上的连通结构相连通，导丝2包括相互分离的第一导丝21和第二导丝22，第一导丝21的后端连接于操作部3后端的插拔结构，第二导丝22通过固 定工艺固定于导管1内部。A second embodiment of the present invention discloses an expanded balloon catheter comprising a guide wire 2 penetrating inside the catheter 1. The catheter 1 is fixedly coupled to the operation portion 3 at one end thereof, and has a distal end of the catheter 1 away from the operation portion 3 The balloon 4, the lumen of the catheter 1 and the lumen of the balloon 4 are communicated by a communication structure disposed on the catheter 1, and the guide wire 2 includes a first guide wire 21 and a second guide wire 22 which are separated from each other, and the first guide wire 21 The rear end is connected to the insertion and extraction structure at the rear end of the operation portion 3, and the second guide wire 22 is fixed The process is fixed inside the conduit 1.
本实施例是第一实施例的变形例，如图2所示，本实施例与第一实施例的不同之处在于：导管1远离所述操作部3的一侧设置尖端导管23，第二导丝22远离操作部3延伸至尖端导管23的外部，第二导丝22的位于尖端导管23外部的部分设置为球状体结构6,即第二导丝22的头部焊接或一体形成球状体结构6，即形成带有球头的导丝。This embodiment is a modification of the first embodiment. As shown in FIG. 2, the present embodiment is different from the first embodiment in that a catheter 1 is provided with a tip catheter 23 away from the side of the operation portion 3, and a second The guide wire 22 extends away from the operating portion 3 to the outside of the tip catheter 23, and the portion of the second guide wire 22 that is outside the tip catheter 23 is provided as a spherical body structure 6, that is, the head of the second guide wire 22 is welded or integrally formed into a spheroid Structure 6, that is, forming a guide wire with a ball head.
这样可达到以下效果：1.减少导管材料，降低成本；2.较细的导丝在***过程中更好地起到引导作用；3.球状体结构的设计最大程度地避免了细长状的导丝***对输尿管内壁的摩擦损伤。优选地，导丝2为金属导丝，金属导丝可以用镍钛合金或不锈钢等金属材料，进一步优选为镍钛合金。镍钛合金是一种形状记忆合金，形状记忆合金是能将自身的塑性变形在某一特定温度下自动恢复为原始形状的特种合金。它的伸缩率在20％以上，疲劳寿命达1*10的7次方，阻尼特性比普通的弹簧高10倍，其耐腐蚀性优于目前最好的医用不锈钢，因此可以满足各类工程和医学的应用需求，是一种非常优秀的功能材料。记忆合金除具有独特的形状记忆功能外，还具有耐磨损、抗腐蚀、高阻尼和超弹性等优异特点。利用镍钛合金作为金属导丝，可大大延长器械的使用寿命，降低器械损耗率。This can achieve the following effects: 1. Reduce the catheter material and reduce the cost; 2. The thinner guide wire can better guide during the insertion process; 3. The design of the spheroid structure avoids the slender shape to the greatest extent. The guide wire is inserted into the frictional damage to the inner wall of the ureter. Preferably, the guide wire 2 is a metal guide wire, and the metal guide wire may be a metal material such as a nickel titanium alloy or a stainless steel, and more preferably a nickel titanium alloy. Nickel-titanium alloy is a shape memory alloy, which is a special alloy that can automatically restore its plastic deformation to its original shape at a certain temperature. Its expansion rate is above 20%, the fatigue life is up to 1*10, the damping power is 10 times higher than that of ordinary springs, and its corrosion resistance is better than the best medical stainless steel at present, so it can meet various engineering and Medical application needs are a very good functional material. In addition to its unique shape memory function, memory alloys are also resistant to wear, corrosion, high damping and superelasticity. The use of nickel-titanium alloy as a metal guide wire can greatly extend the service life of the instrument and reduce the loss rate of the instrument.
综上所述，本发明所涉及的扩张球囊导管，包括相互分离的第一导丝和第二导丝，第一导丝可通过导管后端的开口进行插拔，从而使得导丝腔和注液腔可共用同一个导管腔体，无需另外设置注液腔，或者无需在导丝表面另外设置保护膜对导丝进行保护，如此大大减小了本发明的扩张球囊导管的直径，从而使得本发明的扩张球囊导管可通过内窥镜的器械通道***人体内需要扩张的狭窄管体或者腔体，实现可视化操作，具有很好的实用价值。In summary, the dilatation balloon catheter of the present invention comprises a first guide wire and a second guide wire separated from each other, and the first guide wire can be inserted and removed through the opening at the rear end of the catheter, thereby causing the guide wire lumen and the injection. The liquid chamber can share the same catheter cavity, no need to additionally set the injection cavity, or it is not necessary to provide a protective film on the surface of the guide wire to protect the guide wire, thus greatly reducing the diameter of the expanded balloon catheter of the present invention, thereby The expandable balloon catheter of the present invention can be inserted into the narrow tube body or cavity of the human body through the instrument channel of the endoscope to realize visual operation, and has good practical value.
本发明所涉及的扩张球囊导管可用于泌尿***(输尿管)，消化***(胆管，胰管)呼吸***(气道)人体腔道狭窄的扩张，但不限于此，本发明所涉及的扩张球囊导管也可以作为封堵装置使用，例如，导管1的前端从输尿管壁和结石之间的缝隙***，达到结石的上游甚至达到宽大的肾盂腔时，还可以自导管后端的开口处拔出第一导丝，将导管作为注液腔来注入生理盐水，使得进入结石上游或者肾盂腔的球囊4扩张，在结石上游输尿管腔内膨胀和封堵，使得下游的结石碎片还有冲洗液体无法进入肾盂腔，防止输尿管碎石上逸；或者在肾盂腔的球囊扩张后，将导管1的近端适当牵拉后封堵住肾盂输尿管交界处的肾盂出口，使得任何输尿管的结石、结石碎片、冲洗液体均无法进入肾盂腔，随后进行输尿管结石的碎石处理，如进行激光光纤碎石，待结石处理完毕后抽取球囊内的液体，然后 抽出导管。实际操作中，可选择多次扩张球囊来调节球囊大小，使得球囊更好地与输尿管内壁贴合，紧密封堵输尿管结石，防止输尿管碎石上逸，便于手术操作,提高碎石成功率。。The dilatation balloon catheter according to the present invention can be used for urinary system (ureter), digestive system (biliary duct, pancreatic duct) respiratory system (airway), and the expansion of the human body stenosis, but is not limited thereto, and the expansion ball according to the present invention The balloon catheter can also be used as a occlusion device. For example, the front end of the catheter 1 is inserted from the gap between the ureter wall and the stone, and when the stone reaches the upstream of the stone or even reaches the large renal pelvic cavity, the first step can be pulled out from the opening at the rear end of the catheter. A guide wire is used as a liquid injection cavity to inject physiological saline, so that the balloon 4 entering the upper part of the stone or the renal pelvic cavity is expanded, and is expanded and blocked in the ureteral cavity upstream of the stone, so that the downstream stone fragments and the flushing liquid cannot enter. The renal pelvis cavity prevents the ureteral lithotripsy from escaping; or after the balloon of the renal pelvic cavity is dilated, the proximal end of the catheter 1 is properly pulled and the renal pelvis outlet at the junction of the renal pelvis and ureter is blocked, so that any ureter stones, stone fragments, and rinsing liquid Can not enter the renal pelvic cavity, and then the treatment of ureteral stones, such as laser fiber lithotripsy, after the stone treatment is completed The liquid in the balloon, then Pull out the catheter. In actual operation, the balloon can be expanded multiple times to adjust the size of the balloon, so that the balloon fits better with the inner wall of the ureter, tightly seals the ureteral calculi, prevents the ureteral stone from escaping, facilitates the operation, and improves the success rate of the stone. .
此外，本发明所上述实施例仅例示性说明本发明的原理及其功效，而非用于限制本发明。任何本领域技术人员皆可在不违背本发明的精神及范畴下，对上述实施例进行修饰或改变。因此，本领域技术人员在未脱离本发明所揭示的精神与技术思想下所完成的一切等效修饰或改变，仍应由本发明的权利要求所涵盖。 In addition, the above-described embodiments of the present invention are merely illustrative of the principles of the present invention and its effects, and are not intended to limit the present invention. Modifications or variations of the above-described embodiments may be made by those skilled in the art without departing from the spirit and scope of the invention. Therefore, all equivalent modifications or changes made by those skilled in the art without departing from the spirit and scope of the invention are still covered by the appended claims.

Claims (10)

  1. 一种扩张球囊导管，包括导管(1)和穿设于所述导管(1)内部的导丝(2)，所述导管(1)一端固定连接有操作部(3)，在远离所述操作部(3)的所述导管(1)的远端外侧包覆有球囊(4)，所述导管(1)腔体和所述球囊(4)内腔由设置在导管(1)上的连通结构相连通，其特征在于，所述导丝(2)包括在所述球囊(4)内腔内相互分离的第一导丝(21)和第二导丝(22)，所述第一导丝(21)的后端连接于所述操作部(3)的插拔结构，所述第二导丝(22)通过固定工艺固定于所述导管(1)的另一端。An expansion balloon catheter comprising a catheter (1) and a guide wire (2) disposed inside the catheter (1), the catheter (1) is fixedly connected with an operation portion (3) at one end thereof, away from the The distal end of the catheter (1) of the operating portion (3) is covered with a balloon (4), and the lumen of the catheter (1) and the lumen of the balloon (4) are disposed in the catheter (1) The upper communication structure is in communication, characterized in that the guide wire (2) comprises a first guide wire (21) and a second guide wire (22) separated from each other in the inner cavity of the balloon (4). The rear end of the first guide wire (21) is connected to the insertion and extraction structure of the operation portion (3), and the second guide wire (22) is fixed to the other end of the catheter (1) by a fixing process.
  2. 如权利要求1所述的扩张球囊导管，其特征在于，所述导管(1)在所述球囊(4)中的管体区域相互分离为第一管体(11)和第二管体(12)，所述第一管体(11)的后端固定连接于所述操作部(3)，所述第二管体(12)的外壁固定连接于所述球囊(4)，所述第一管体(11)和所述第二管体(12)之间的断面相对构成连通通道(13)，所述连通通道(13)作为所述连通结构将所述导管(1)腔体和所述球囊(4)内腔相连通，所述第二导丝(22)***所述第一管体(11)内的***深度大于在所述球囊(4)膨胀时所述第一管体(11)和所述第二管体(12)之间的分离距离。The dilatation balloon catheter according to claim 1, wherein said catheter (1) is separated from each other in a body region of said balloon (4) into a first tube body (11) and a second tube body (12), a rear end of the first tube body (11) is fixedly connected to the operation portion (3), and an outer wall of the second tube body (12) is fixedly connected to the balloon (4). The cross section between the first pipe body (11) and the second pipe body (12) oppositely constitutes a communication passage (13), and the communication passage (13) serves as the communication structure to connect the duct (1) cavity The body is in communication with the lumen of the balloon (4), the insertion depth of the second guide wire (22) inserted into the first tube (11) is greater than when the balloon (4) is expanded The separation distance between the first tube body (11) and the second tube body (12).
  3. 如权利要求2所述的扩张球囊导管，其特征在于，所述球囊(4)中的所述第一管体(11)的管壁上设有一个或多个通孔(14)，所述通孔(14)作为所述连通结构连通所述第一管体(11)腔体和所述球囊(4)内腔，所述通孔(14)设置在所述第二导丝(22)***所述第一管体(11)内的端部和所述第一管体(11)与所述球囊(4)的连接处之间。The dilatation balloon catheter according to claim 2, wherein one or more through holes (14) are provided in the wall of the first tube (11) in the balloon (4), The through hole (14) communicates as the communication structure to connect the first tube body (11) cavity and the balloon (4) inner cavity, and the through hole (14) is disposed on the second guide wire (22) being inserted between the end portion of the first tube body (11) and the junction of the first tube body (11) and the balloon (4).
  4. 如权利要求2所述的扩张球囊导管，其特征在于，所述球囊(4)前端与所述第二管体(12)的相连接之处设有显影环(5)，所述显影环(5)包覆区域的所述导管的内部封闭。The dilatation balloon catheter according to claim 2, wherein a developing ring (5) is provided at a position where the front end of the balloon (4) is connected to the second tube (12), and the developing The interior of the conduit of the ring (5) cladding region is closed.
  5. 如权利要求1所述的扩张球囊导管，其特征在于，所述导管(1)远离所述操作部(3)的一侧设置尖端导管(23)，所述第二导丝(22)延伸至所述尖端导管(23)内，所述第二导丝(22)位于所述尖端导管(23)中的端部与所述尖端导管(23)顶端的距离为0.5mm-2mm。 The dilatation balloon catheter according to claim 1, wherein a tip catheter (23) is disposed on a side of the catheter (1) away from the operating portion (3), and the second guide wire (22) extends To the tip catheter (23), the end of the second guide wire (22) located in the tip catheter (23) is at a distance of 0.5 mm to 2 mm from the tip end of the tip catheter (23).
  6. 如权利要求1所述的扩张球囊导管，其特征在于，所述导管(1)远离所述操作部(3)的一侧设置尖端导管(23)，所述第二导丝(22)远离所述操作部(3)延伸出所述尖端导管(23)的外部，所述第二导丝(22)的位于所述尖端导管(23)外部的部分设置为球状体结构(6)。The dilatation balloon catheter according to claim 1, wherein a tip catheter (23) is disposed on a side of the catheter (1) away from the operation portion (3), and the second guide wire (22) is away from The operating portion (3) extends outside the tip catheter (23), and the portion of the second guide wire (22) located outside the tip catheter (23) is provided as a spherical body structure (6).
  7. 如权利要求1所述的扩张球囊导管，其特征在于，所述操作部(3)包括手持部(31)，所述导管(1)穿设于所述手持部(31)内部，形成连通于所述球囊(4)内腔的液体通道。The dilatation balloon catheter according to claim 1, wherein the operation portion (3) includes a hand-held portion (31), and the catheter (1) is disposed inside the hand-held portion (31) to form a communication. a liquid passage in the lumen of the balloon (4).
  8. 如权利要求7所述的扩张球囊导管，其特征在于，所述手持部(31)的后端设有二通旋塞(32)，所述二通旋塞(32)的塞子上设置有旋塞通孔，当所述旋塞通孔与所述导管(1)的管口同轴时，打开所述液体通道；当所述旋塞通孔与所述导管(1)的管口垂直时，关闭所述液体通道。The dilatation balloon catheter according to claim 7, wherein a rear end of the hand-held portion (31) is provided with a two-way cock (32), and a plug of the two-way cock (32) is provided with a cocking plug a hole that opens the liquid passage when the cock through hole is coaxial with the nozzle of the conduit (1); closes when the cock through hole is perpendicular to the nozzle of the conduit (1) Liquid channel.
  9. 如权利要求1所述的扩张球囊导管，其特征在于，所述球囊(4)后端的所述导管(1)外周面上设有刻度线。The dilatation balloon catheter according to claim 1, wherein a scale line is provided on an outer circumferential surface of said catheter (1) at a rear end of said balloon (4).
  10. 如权利要求7所述的扩张球囊导管，其特征在于，所述操作部(3)的后端设有外螺纹(33)，所述外螺纹(33)可套接螺丝帽(35)，所述螺丝帽(35)作为所述插拔结构与所述第一导丝(21)的后端相连接，可通过拆卸所述螺丝帽(35)来拔出所述第一导丝(21)。 The dilatation balloon catheter according to claim 7, wherein the rear end of the operating portion (3) is provided with an external thread (33), and the external thread (33) can be sleeved with a screw cap (35). The screw cap (35) is connected to the rear end of the first guide wire (21) as the insertion and removal structure, and the first guide wire can be pulled out by disassembling the screw cap (35) ).
PCT/CN2017/106514 2017-10-17 2017-10-17 Dilatable balloon catheter WO2019075634A1 (en)

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US16/651,958 US11504510B2 (en) 2017-10-17 2017-10-17 Dilatable balloon catheter
EP17928900.4A EP3673948B1 (en) 2017-10-17 2017-10-17 Dilatable balloon catheter
JP2020509484A JP6937091B2 (en) 2017-10-17 2017-10-17 Expansion balloon catheter
PCT/CN2017/106514 WO2019075634A1 (en) 2017-10-17 2017-10-17 Dilatable balloon catheter
ES17928900T ES2929743T3 (en) 2017-10-17 2017-10-17 dilatable balloon catheter

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US20200254230A1 (en) 2020-08-13
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